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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Group Asks FDA for More Warning Information on Dietary Supplement Labels

A public health group is calling on the US Food and Drug Administration (FDA) change the warning labels on all herbal and dietary supplements to include more information about how the products might cause side effects, interact with pharmaceuticals and affect pregnant women.

The dietary supplement industry, led by the Natural Products Association (NPA), has attacked the methodology behind the attorney general's findings, claiming they relied upon an ill-suited test known as DNA fingerprinting. The group claims that the extraction process used to create the supplements would have destroyed most DNA fragments in the supplements, meaning the tests would need to be able to determine if they contained authentic ingredients. Subsequent, industry-funded testing found the products to contain the labeled ingredients.

In their petition, PPS cites the NY attorney general's investigation, saying it is evidence the products may not be meeting "federal standards and good manufacturing procedures as outlined by the FDA."

"Over the past ten years, many tests done by the FDA and FTC [have] shown that herbal and dietary supplements did not contain any of the herbals listed on their labels, with many of these products being sold to consumers and patients," the group wrote. "These herbal and dietary supplements showed that the labeled medicinal herbs often contained cheap fillers such as powdered rice, asparagus and house plants, and in some cases substances that could be dangerous to those with allergies."

The group questioned why FDA would require these labeling restrictions on prescription pharmaceutical products and not on dietary supplements.

PPS also notes that many supplements can cause adverse reactions when taken with pharmaceutical products, including decreasing the efficacy of the pharmaceutical substance. "There are very few warnings with herbal and dietary supplements to consumers regarding these dangerous drug interactions," the petition notes.

Call for Action, but Little Authority to Act

Unfortunately for the petitioner, its suggested course of action may be well beyond the regulatory authority of FDA. PPS asks FDA to require supplement products to be labeled with warnings similar to those contained on over-the-counter drugs.

However, FDA's authority over dietary supplement labeling is limited under the Dietary Supplement Health and Education Act (DSHEA) of 1994, which treats supplements more similarly to food products than drug products. As long as those products do not contain pharmaceutical ingredients and are not promoted using claims limited to drug products, FDA has little authority to regulate them as they would a prescription or over-the-counter pharmaceutical product.

PPS is not the first group to call for better adverse event labeling on supplements. In 2013, Sens. Dick Durbin and Richard Blumenthal introduced legislation that would require supplements to contain information about if an ingredient in the supplement is known to cause adverse events, drug interactions or risks to children or pregnant women. The bill was not approved.